14th Mar 2011 07:00
14 March 2011
LSE: VER
Americas Licensing Deal for tosedostat
As announced separately today, Chroma Therapeutics Limited and Cell Therapeutics, Inc. (CTI), a US public company listed on the Nasdaq stock exchange, have entered into a licensing deal for the rights to tosedostat in North, Central and South America.
Tosedostat has been granted orphan drug status for Acute Myeloid Leukemia (AML) by both the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Under the terms of the license announced today, CTI will be responsible for further development of tosedostat and intends to progress it into Phase III studies of AML to start in Q4 2011.
Vernalis licensed tosedostat to Chroma in November 2003 and is entitled to royalties on commercial sales. Chroma has undertaken both Phase I and II studies of tosedostat both as a single oral agent and in combination with other chemotherapeutic agents. Studies have demonstrated significant anti-tumor responses without the typical side effects of conventional, non-targeted cytotoxic therapies. Initial indications included AML, myelodysplastic syndromes (MDS) and multiple myeloma.
Ian Garland commented: "We are delighted with today's announcement of Cell Therapeutics licensing tosedostat rights for North, Central and South America and the plans to progress it into Phase III as a potential treatment of AML, a disease with an estimated 12,000 new cases last year in the US alone".
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Enquiries:
Vernalis Contacts
| |
Ian Garland, Chief Executive Officer | +44 (0) 118 989 9360 |
David Mackney, Chief Financial Officer
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Brunswick Group
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Jon Coles | +44 (0) 20 7404 5959 |
Justine McIlroy | |
Taylor Rafferty
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Rob Newman | +44 (0) 20 7614 2900 |
Faisal Kanth |
Notes to Editors
About Vernalis
Vernalis is a development stage pharmaceutical company with significant expertise in taking promising product candidates along a commercially-focused path to market. The Group has one marketed product, frovatriptan for the acute treatment of migraine, and nine candidates in development, seven of which are designated priority programmes. Three of these priority programmes are currently unpartnered and four are partnered. Pipeline programmes are derived from both our own research activities where we have significant expertise in fragment and structure based drug discovery, as well as from collaborations. Our technologies, capabilities and products are endorsed by collaborations with Biogen Idec, Chiesi, Endo, GSK, Lundbeck, Menarini, Novartis and Servier.
About AML
AML is a hematologic cancer that is an aggressive, fast -growing cancer that starts inside the bone marrow with the production of abnormal blood cells. The American Cancer Society estimates that 12,330 new cases of acute myeloid leukemia (AML) will be diagnosed and approximately 8,950 deaths from AML will occur in the U.S. in 2010. AML is generally a disease of older people, with the average age of onset for AML of approximately 67 years. There remain a substantial proportion of elderly patients who do not receive intensive chemotherapy due to their inability to tolerate such regimens, and other risk factors. Therefore, there is a significant unmet medical need in developing a well-tolerated and effective treatment for these patients.
Product | Indication | Pre-Clinical | Phase I | Phase II | Phase III | Marketed | Marketing Rights |
Priority Programmes | |||||||
CNS Programmes | |||||||
Frovatriptan | Acute Migraine | X | Menarini & Endo Pharma | ||||
2nd generation A2A antagonist | Parkinson's Disease | X | Biogen Idec | ||||
V158866 | Pain | X | Worldwide | ||||
Oncology Programmes | |||||||
AUY922 | Cancer | X | Novartis | ||||
CHR2797 | Cancer | X | Chroma Therapeutics | ||||
HSP990 | Cancer | X | Novartis | ||||
V158411 | Cancer | X | Worldwide | ||||
Other Therapeutic Areas | |||||||
V85546 | Inflammatory Disease | X | Worldwide | ||||
Legacy programmes | |||||||
V10153 | Ischaemic Stroke | X | Worldwide | ||||
RPL554 | Asthma/ Allergic Rhinitis | X | Verona Pharma |
For further information about Vernalis, please visit www.vernalis.com
Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products, the Company's ability to find partners for the development and commercialisation of its products, as well as the Company's future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of Frova® and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.
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